Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Thanks WeeZuhl, I am assuming that was the original OxyContin rather than the currently marketed abuse resistant version.

Hello JamesF1, the pivotal bioequivalence PR in my previous post is in fact referring to a generic version of the currently-marketed ADF OxyContin. The bioequivalence studies have been done, and the ANDA application was submitted in 2017. I would hope any bio-equivalency issues have been resolved by now. I believe what is preventing the application from moving forward is the lack of human abuse liability studies. The company has to prove our generic formula is just as difficult to abuse as the brand name, but exactly what that means is uncertain because the FDA has not yet approved any generics of ADF OxyContin or any other brand name ADF. Now that cash is available, the missing HAL studies can be pursued. It is unknown how many companies have already gotten in line with completed HAL studies or when the FDA will actually give one of them an approval. At least 4 companies, including Epic, have already beaten Purdue et al in patent court.

Sep 20, 2017:

Elite Pharmaceuticals Files ANDA For Oxycodone Hydrochloride Extended Release
NORTHVALE, N.J., Sept. 20, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.

"I am very pleased with this filing of an ANDA for a generic version of OxyContin®. This is our fourth ANDA filing in the past 15 months and is a key addition to our portfolio," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent pain products and attractive niche generics."